Removal of disease such as atherosclerotic plaque, thrombus and other types of obstructions and partial obstructions from internal body lumens or cavities using interventional catheters having operating heads that function to break down and/or remove occlusive material using mechanical structures such as cutter assemblies, abrasive materials and/or shaped tools, ablation instruments employing modalities such as RF, laser or radiation-induced ablation modalities, ultrasound, fluid jets or fluid agitation and the like, are well-established interventional techniques. Other types of interventional catheters may provide fluid infusion and/or aspiration alone or in combination with another diagnostic or treatment modality. Yet other types of interventional catheters may be employed for delivery of devices or compositions to an interventional site.
Many material removal devices and interventional catheters incorporate mechanical aspiration systems to remove material from the interventional site and some systems incorporate, or are used in conjunction with, other mechanisms such as distal filters for preventing removed material from circulating in the blood stream. Some interventional catheter systems incorporate or are used in conjunction with a fluid infusion system providing delivery of fluids to an interventional site. Interventional catheter systems may also incorporate or be used in conjunction with imaging systems and other types of complementary and/or auxiliary tools and features that facilitate desirable placement and operation of the system during an interventional procedure. Despite the many and varied approaches to material removal systems, many challenges remain in providing systems for removing material from an internal body site safely and reliably and without causing complications. The safety and reliability of the system, and the ability of the operator to monitor the intervention, acquire and evaluate feedback during the intervention, and control the system conveniently and with assurance and responsiveness, is critical.
Interventional catheters are generally assembled with and/or associated with or mounted to a housing providing an enclosure for drive mechanisms, fluid manifolds and management systems, and the like, with the housing generally located at a proximal region of the catheter. Some types of interventional catheters employ a single operational and control component interfacing with and mounted to the interventional catheter at a proximal region of the catheter. In devices that interface with a single operating and control component, system and operating components may be housed in the control component and user interface controls for operating the catheter may be provided on the operating and control component. Various control features for activating and operating the interventional catheter, its aspiration and/or infusion systems, and other functional systems may be provided. Status indicators, system read-outs and operating information may also be provided on interventional catheter operating and control components.
Some interventional catheter systems employ a console-type controller that houses non-disposable components such as pumps, drive systems, electrical, electronic, vacuum and fluid control systems, and the like, alone or in combination with another intermediate control device that provides operator control options and, in some cases, feedback information. In interventional catheter systems employing an intermediate control device, the intermediate control device is typically located at or near a proximal region of the interventional catheter. The intermediate control device may be positioned within or close to the sterile field during a procedure, while the console-type controller may be positioned outside the sterile field during a procedure. Interventional catheter systems employing both a console-type controller and an intermediate control device are described, for example, in PCT International Publication WO 2008/042987 A2, the disclosure of which is incorporated herein by reference in its entirety. Patients may also be monitored during an interventional procedure using separate or integrated systems, such as fluoroscopic or other visualization systems, vital sign monitoring systems, and the like.
During an interventional procedure, some of the operating and feedback systems used during the procedure are monitored audibly and/or visually following set-up and must simply be within the medical professionals' visual and/or auditory field during the intervention. Other operating and feedback systems, including at least some features of interventional catheter controller(s), are actuated and/or manipulated by an operator to position, move, operate and adjust operation of the interventional catheter during an intervention. The interventional catheter control features that require operation and manipulation during an intervention should be designed and positioned to facilitate convenient and effective operator access and control during the intervention. Providing convenient and effective access to a selection of operating and monitoring systems, or to all of the interventional catheter operating and monitoring systems, to medical personnel during an intervention is important and may be crucial to the success and efficacy of an intervention and the patient's health and recovery. The present disclosure is directed to interventional catheter assemblies and interventional catheter control systems that provide improved convenience, effectiveness and mobility during an intervention.